Senior Regulatory Affairs Specialist

Medtronic

Mounds View, MN, United States
Base: $110,200 to $138,000 py; bonus/equity: not s...
Hybrid
510(k) submissions for us class ii medical devices
Eu mdd and mdr technical documentation
Regulatory support for iso compliance
The role involves developing regulatory strategies and preparing submissions for global markets

Job Summary

  • The role involves developing regulatory strategies and preparing submissions for global markets.
  • Candidates will work on total product life-cycle regulatory activities including product development and post-market changes.
  • The position offers a competitive salary and comprehensive benefits package.

Matching Summary

The role involves developing regulatory strategies and preparing submissions for global markets.

Salary

Base: $110,200 to $138,000 per year; Bonus/Equity: Not specified; Benefits: Health, Dental and vision insurance, Tuition assistance

Skills & Requirements

Must-have

  • 510(k) submissions for US Class II medical devices
  • EU MDD and MDR technical documentation
  • Regulatory support for ISO compliance

Nice-to-have

  • Experience with post-market changes
  • Strong communication skills
  • Ability to work in a hybrid model

Key Requirements

  • Master’s degree in Regulatory Affairs or related field
  • Three years of experience in Regulatory Affairs
  • Experience with QSR 21 CFR 820 compliance

Work Rights

Not specified

Tailored Resume

Cover Letter